Proclinical has been retained by a cutting edge, biopharmaceutical company to appoint a Global Head of Quality for their commercial manufacturing sites. This is a position which is high impact & highly visible across the entire Quality organisation. This person will be pivotal in leading significant organisational change as well as overseeing all aspects of Quality Assurance, linking business and manufacturing processes to customer needs and regulatory compliance.
You will be responsible for quality systems and product quality characteristics at internal commercial manufacturing facilities. This role also involves providing QA oversight for Global Engineering, Manufacturing Excellence, and Global Analytical Operations, driving continuous improvement and fostering a culture of quality within the organization. FDA inspection readiness and hosting experience is mandatory. Ideally you will have expertise in biologicals/parenteral/GTx product modalities.
This is a unique, once in a career opportunity to shape the global quality organisation in an established but innovative organisation supplying life changing and lifesaving medicines for serious diseases globally.
It should appeal to a charismatic leader that is able to think strategically, set the vision for a global Quality organisation and execute on that strategy leading, change in multiple locations with a common goal and bring colleagues on a journey of change. There will be a unique blend of technical, regulatory and leadership challenges in the role.
Key Responsibilities:
- Oversee the Quality organizations across all manufacturing sites.
- Lead and manage Site QA heads and their teams at various manufacturing sites.
- Provide QA oversight for Global Engineering, Manufacturing Excellence, and Global Analytical Operations departments.
- Promote collaborative partnerships with cross-functional teams to prevent potential regulatory or safety risks.
- Responsible for staff and talent management, including performance management.
- Lead the roll-out and ongoing compliance of global quality and compliance systems.
- Promote and guide a quality culture within manufacturing sites and global engineering departments.
- Establish measures that monitor key elements related to Quality.
- Analyse and report product and process quality trends against internal and external guidelines.
- Chair high-impact inspection readiness steering committee (as needed) and ensure appropriate and timely communication to senior management.
- Foster a culture of knowledge and good practices sharing among internal and external QA to drive continuous improvement and innovation.
Requirements:
- Bachelor's degree in a relevant scientific or engineering discipline; advanced degree preferred.
- Significant demonstrable years of experience in the biopharmaceutical industry at a leadership level, with a focus on quality assurance and regulatory compliance.
- Proven experience in leading and managing QA teams across multiple sites and/or within a complex, multinational manufacturing network.
- Experience of US FDA inspection hosting
- Strong knowledge of global regulatory requirements and industry best practices.
- Fluent in English is a must, French is highly desirable but not essential
- European Qualified Person certification (asset).
- Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs.
- Ability to freely travel up to 30% both domestically and internationally
- Ability to have a site presence
Next Steps:
At the client's request, this is a confidential search but please click 'Apply Now' to register your interest and arrange a completely confidential initial conversation with Joshua Godden, who will be spearheading this search. You can also reach out to him directly at J.Godden@Proclinical.com or +44 (0) 203 854 0101.
If there is interest after this initial call, you will be required to sign a Non-Disclosure Agreement (NDA) before full details of the client can be revealed.
About Proclinical:
Proclinical is a leading recruiter in the life sciences sector, dedicated to pairing exceptional talent with top positions globally. Want to stay updated? Follow us and check out our website for live roles and updates www.proclinical.com.
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